S02 36C26025Q0712 0002.pdf

5. PROJECT NUMBER (if applicable)

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2. AMENDMENT/MODIFICATION NUMBER

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

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15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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Contractor

16C. DATE SIGNED

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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

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IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 7

0002 08-25-2025

648-25-3-1555-0015

36C260

Department of Veterans Affairs Network Contracting Office 20 (V4CONT) 1601 E. Fourth Plain Boulevard Building 17, Suite B428 Vancouver WA 98661

36C260

Department of Veterans Affairs Network Contracting Office 20 (V4CONT) 1601 E. Fourth Plain Boulevard Building 17, Suite B428 Vancouver WA 98661

To all Offerors/Bidders

36C26025Q0712

07-01-2025

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 09-03-2025 3PM MDT **

See CONTINUATION Page

648-3650160-1555-820100-2580 SP80K00A3

X 1

The purpose of this amendment is to reopen solicitation 36C26025Q0712 and make changes to the Price/Cost schedule and applicable section of the Statement of Work. The projected period of performance has been changed to 09/22/2025 - 09/21/2026.

1) Solicitation 36C26025Q0712 is hereby amended to decrease the effort listed for CLIN 0002 from 75% to 50% and decrease quantity for CLIN 0002 from 9 months to 6 months. The hour and date for receipt of offers is extended to 09-03-2025 3PM MDT to Jennifer Robles at jennifer.robles1@va.gov.

See continuation pages for full details. All changes are highlighted in yellow.

Jennifer Robles Contracting Officer

VA-VHA-RPOW-2023-0015

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

3.00 MO __________________ __________________

PhD Level Biostatistician

25.0% Effort

Period of performance:

09/22/2025 - 09/21/2026

6.00 MO __________________ __________________

Masters Level Biostatistian

50.0% Effort

6.00 MO __________________ __________________

Masters Level Biostatistician

50.0% Effort

GRAND TOTAL __________________

A.2 – STATEMENT OF WORK

STATEMENT OF WORK (SOW)

1. Contract Title. Biostatistical Support and Data Extraction for the PTSD Trials Standardized Data Repository.

2. Background. To provide researchers, clinicians, patients and policy makers access to posttraumatic stress disorder (PTSD) clinical trial data, the National Center for PTSD (NCPTSD), in partnership with the Agency for Healthcare Research and Quality Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), created the PTSD Trials Standardized Data Repository, or “PTSD Repository”. The overarching purpose of this publicly accessible clinical trials database is to identify randomized controlled trials (RCTs) of PTSD interventions for adults and abstract detailed, standardized data into evidence tables. This work is designed to provide a broad range of stakeholders with up-to-date, comprehensive data on PTSD treatment research. The work was initiated in 2018, in collaboration with Dr. Maya O’Neil. Regular updates coordinated with NCPTSD have included adding newly published RCTs, additional data elements, and risk of bias (RoB) assessment for all included studies.

VAPORHCS Principal Investigator, Dr. Maya O’Neil, has funds from NCPTSD to maintain, support, update and expand the PTSD Repository, providing annual updates to the database. These updates include abstracting 300+ variables, calculating standardized effect sizes, conducting of RoB assessments for newly added studies, contacting corresponding study authors to obtain relevant unpublished data and inform them on inclusion of the study in the Repository, and creating an executive summary of findings, up to date presentations with summary statistics and data visualizations, and a full report with updated summary visualizations and complete evidence tables. Annual updates include an estimated 40-55 studies per year and require advanced data analyst and biostatistician support for the data extraction, data compilation, and data visualization, and expertise beyond what can be met by VA research staff.

In order to achieve the deliverables outlined by the PTSD Repository, this work requires the advanced scientific and technical services of data analysts and biostatisticians who are specifically trained in evidence synthesis and related work necessary for the establishment and maintenance of Data Repositories, and who have experience using Agency for Healthcare Research and Quality (AHRQ) evidence synthesis methods for this work.

3. Scope.

The vendor awarded this contract must meet the specific scope requirements in order to effectively complete the tasks:

• Vendor must have experience conducting evidence synthesis and data repository work for the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center program network.

• Vendor staff must include multiple part-time individuals who have advanced expertise in extracting data for evidence synthesis, meta-analysis and data repositories; clinical training and expertise related to healthcare and PTSD are required. Multiple individuals are required because any one individual does not have sufficient expertise in all required services (assessing RoB, consultation with web developers for dissemination on VA websites, data extraction, data analysis, summarizing findings, data visualizations of key findings, presentation, etc.) nor in all statistical methods; a team approach involving frequent individual and group meetings is typically needed to successfully complete all the tasks required. The contracted individuals will serve as key members of the PTSD Repository’s multidisciplinary research team.

• Vendor staff must be Masters or doctoral level Research Data Analysts, Biostatisticians, or Data Engineers, with specific training in evidence synthesis and online meta-analysis platforms. Effort required to meet project aims: 0.25 FTE at the PhD level, and 1.0 FTE at the Masters level is required for the duration of the contract.

• Staff must maintain active research portfolios in both applied and methodology research. They have expertise in most modern methods, such as (but not exclusively) clinical trials, RoB assessment using Cochrane RoB 2, meta-analysis/individual participant level meta-analysis, multilevel modeling and missing data analyses, data visualization, complex sampling, and advanced data extraction methodology. All members actively publish manuscripts in top international journals and present at professional meetings.

• Familiarity and expertise in: conducting literature searches, data abstraction, calculating standardized effect sizes, assessing RoB, contacting corresponding study authors to obtain relevant unpublished information and inform them on inclusion of the data in the Repository, and creating a full report including an executive summary of findings, updated summary visualizations, complete evidence tables, and presentations.

• Experience creating data repositories for the purpose of facilitating systematic reviews, and experience contributing data from data repositories to one or more online meta-analysis platforms

• Demonstrated scientific rigor and expertise involving VA research

• Demonstrated experience in data extraction and advanced quantitative methods including meta-analysis

• Established relationships with the stakeholders who have expertise in the PTSD Standardized

Data Repository

The Contractor agrees to provide the services in accordance with the Statement of Work and VA policies for research, under the direction of Dr. Maya O’Neil.

Contractors will provide the below-detailed services and deliverables. Specific details regarding each position are outlined with a Statement of Work. All projects will be initiated by the contractor through strict adherence to the VA approved protocols.

4. Specific Tasks.

The personnel provided for this contract will work with the Principal Investigator(s) to complete objectives outlined by the NCPTSD. The individual will have expertise in the area in which they are being contracted to work. Analyses and associated reports will also be completed for reporting, funding agency requirements, as well as for any scientific abstracts and peer-reviewed publications.

The FTE required to complete the specific tasks and deliverables are 0.25 FTE of a PhD level Biostatistician and 1.0 FTE of Masters level Biostatisticians for the duration of the contract.

Tasks and Deliverables for Systematic Review Update of the PTSD Repository:

1. Training and consultation, which includes

a. Completion and maintenance of any necessary trainings

b. Consultations with project PI and staff on PTSD Repository protocols and procedures.

2. Literature Searching and Screening for Inclusion

a. Literature search will include multiple electronic databases. Search strategy will identify eligible studies testing PTSD interventions from 6 months prior to the date of the last report’s final search to present

b. Review abstracts and full text using established inclusion/exclusion criteria. (Dual review)

c. Consensus on articles for inclusion.

3. Technical Expert Panel

a. A Technical Expert Panel will be invited for a discussion with project PI and NCPTSD.

b. Topic(s) to be discussed will be determined in consultation with NCPTSD.

4. Data Abstraction and Data Management

a. Abstracting 300+ variables; may abstract additional data elements. For each included study, data will be abstracted into a detailed evidence table.

b. Calculate and add standardized effect sizes for all continuous PTSD outcomes, provided necessary data is available.

c. Contact corresponding study authors of newly included studies to obtain relevant unpublished data and inform authors of the inclusion of their study in the report.

5. Assessment of Methodological Risk of Bias (RoB) of Individual Studies

a. Assess RoB using Cochrane RoB 2 for each of the studies added in the update

b. Second review required for accuracy check and consensus.

c. Potentially add additional elements to the expanded RoB assessment

6. Check-in with NCPTSD

a. Monthly meeting updates with NCPTSD will address any project-related issues and update on overall progress and included studies

b. Discussion of areas of controversy or uncertainty, including coding decisions

c. In-process evidence tables will be shared to inform update calls

7. Update Analyses and Database

a. Update analyses in previous report to reflect all included studies (eligible studies from new literature search and studies included in the prior reports).

b. Conduct additional analysis to summarize newly added studies, including study and sample characteristics and PTSD outcome measures.

8. Report and Evidence Summary

a. Update the report by adding eligible studies published studies from 6 months prior to the date of the last report’s final search to present (last search date no later than 12 weeks prior to draft report submission).

b. The report shall summarize the full dataset and highlight changes made during this update (e.g., number of studies added, additional variables included, etc.). The report will be appropriate for a scientific audience and include an abstract, evidence summary, background, methods section, results, and discussion. The evidence summary will be approximately 2-6 pages in length prepared for a lay audience.

c. The report will be delivered as a Microsoft Word document. Text should be written in plain language (see www.plainlanguage.gov for guidance), as close as possible to a 7th grade level. Visuals, including graphics and charts should be used to accompany the text throughout.

d. The detailed evidence tables will be provided as an appendix to the report.

e. The report and evidence summary will be sent to NCPTSD and invited peer reviewers. Feedback will be incorporated into the final report.

9. Presentation

a. A PowerPoint presentation summarizing the systematic review update.

10. Manuscript Preparation (optional)

a. Draft, review, edit, and discuss analysis sections for manuscripts related to the PTSD Repository when requested.

5. Performance Monitoring (if applicable).

The VA Principal Investigator (PI) shall monitor contractor performance throughout the performance period of the contract to determine how the Contractor is performing against the performance objectives and verify the completion of deliverables. The Contractor shall meet with the PI at the beginning of the contract award and as needed to review the PTSD Repository protocol with the PI. The PI will conduct periodic quality reviews by attending data services-related meetings and reviewing work completed by the analyst and/or statistician. Monthly check ins will also occur with NCPTSD.

6. Security Requirements.

The personnel will work with publicly available PTSD data and will not require background investigations or security clearances.

No sensitive VA data is involved with this work, as such, Contracted work does not require data transfer or data use agreements.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

Not Applicable

8. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work.

Additional work may result from successful completion of this project. Should the NCPTSD provide additional funding to VAPORHCS to maintain/expand the PTSD Repository in future years, a contract modification or new contract acquisition may be required.

b. Identification of Potential Conflicts of Interest (COI).

No organizational COI’s exist currently, and given the nature of the services being requested, it is not anticipated that the contractor will be exposed to information that could result in a Conflict of Interest.

e. Inspection and Acceptance Criteria. Not Applicable

9. Risk Control

No anticipated risks.

10. Place of Performance.

The work will be performed at the contractor site. No need for travel is anticipated.

11. Period of Performance.

The period of performance for this contract is a base period of 12-months.

Base Year: 09/22/25- 09/21/26

12. Delivery Schedule.

Deliverable Date Due (from award)

Training and Consultation 4 Weeks

Literature Searching and Screening for Inclusion Ongoing, last search date no later than 12 weeks prior to draft report submission

Data Abstraction and Data Management Ongoing, but must be completed before final report

Risk of Bias Ongoing, but must be completed before final report

Update Analyses and Database Ongoing, but must be completed before final report

Draft Report and Draft Evidence Summary 50 Weeks

NCPTSD review (optional peer review) 52 weeks

Final Report and Final Evidence Summary 52 weeks

PowerPoint Slide Deck & Presentation 52 weeks

Manuscript Preparation (as needed) 4 weeks from request

If for any reason, any deliverable cannot be delivered in the timeframe agreed upon, the Contractor shall provide a written explanation to the PI; this written transmittal shall include a firm commitment of when the work shall be completed. This notice needs to cite the reasons for the delay, and the impact on the overall project.